CUTANEOUS (BAR) ELECTRODE

• K Number: K991769
• Device Name: CUTANEOUS (BAR) ELECTRODE
• Manufacturer: NEURO SUPPLIES, INC.
• Date Cleared: 1999-08-18 ( 86 days)
• Product Code: GXY
• Regulation Number: 882.1320
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

Cutaneous (Bar) Electrode is intended for non-invasive use as a recording (active/reference) or stimulating electrode during electromyographic (EMG), Nerve Conduction Studies(NCS), and Evoked Potentials (EP) recordings.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for several electrodes (cutaneous, digital ring, cutaneous disc, and cutaneous ground electrodes). It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The letter confirms that the devices are substantially equivalent to previously marketed devices and can therefore be marketed.

Therefore, I cannot provide the requested information based on the input text. The provided document is a regulatory clearance, not a technical report detailing performance criteria or study results.

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).